FDA, 토마토 항산화 성분 리코펜, 암 위험 감소 근거 없다

FDA, 토마토 항산화 성분 리코펜, 암 위험 감소 근거 없다 결정
2005년 9월 2일 “동서양 대체의학”에 게시한 “토마토의 소위 항산화 성분 리코
펜에 대해”를 참조하시기 바랍니다.
 
2005년 11월 8일 미 FDA는 리코펜(lycopene), 토마토, 리코펜을 함유한 토마
토에 기초한 식품의 보건 주장 청원에 대해 거절 통지를 발송했습니다. 이때 보
건 주장이란 이런 저런 암 위험 감소 효과입니다. 아래 첨부한 보도 내용을 참조
하시기 바랍니다.

이런 경우 관련 건강식품 기업은 FDA를 상대로 소송하는 것이 유일한 길입니다.
여하튼 미 암협회(American Cancer Society) 인사도 리코펜에 대한 FDA의 결
정이 평가에 노력이 많이 든 합리적인 평가라고 말하고 있습니다. 
 
......................

FDA Denies Lycopene Supplement Health Claims
By Steven Reinberg
HealthDay Reporter
WEDNESDAY, Nov. 9 (HealthDay News) -- The U.S. Food and Drug
Administration has determined that the antioxidant lycopene is not likely
to reduce the risk of cancer.

Supplement maker American Longevity had sought FDA approval to make
cancer-fighting claims for its lycopene supplements. But the agency
concluded that "there is no credible evidence to support qualified health
claims for lycopene, as a food ingredient, component of food, or as a
dietary supplement, and reduced risk of any of the cancers in the
petition."

The malignancies that are supposedly inhibited by lycopene -- an
antioxidant found in red fruits such as tomatoes and watermelon --
include prostate, gastric, ovarian and pancreatic cancer. However, for
each of these cancers, the FDA said a review of studies found there was
"uncertain" or "little scientific evidence" that lycopene conferred any
benefits.

Several years ago, the H.J. Heinz Co. took out full-page ads proclaiming
the health benefits of lycopene, and ketchup sales rose 4 percent. The
FDA ordered the company to stop the ads because such claims required
the agency's approval, according to the Boston Globe.

The FDA's ability to regulate dietary supplements is limited. The agency
can take action against any unsafe dietary supplement after it reaches the
market. Manufacturers do not need to register their products with the
FDA, or get FDA approval before producing or selling dietary
supplements. However, manufacturers must make sure that product labels
are "truthful and not misleading."

The FDA announced its decision on lycopene in a Nov. 8 letter to
American Longevity.

In response, the San Diego-based company said it would sue the agency
within 30 days. "It's a violation of the First Amendment. We have all the
evidence to back up our claim, and we should be able to tell the public,"
said American Longevity spokeswoman Brooke Holve.

American Longevity fought a similar battle over the cancer-prevention
claims made for the mineral selenium. The company's effort got the FDA
to change its position in 2003, and it is hoping that the lawsuit will do
the same for lycopene, Holve said.

Holve said the FDA now allows selenium supplements to say on the label
that they "may reduce the risk of certain cancers. Some scientific
evidence suggests that consumption of selenium may reduce certain forms
of cancer." The label must also say: "The FDA has determined that this
evidence is limited and not conclusive."

Dr. Michael Thun, vice president for epidemiology and surveillance
research at the American Cancer Society, thinks that the position taken
by the FDA on lycopene is well reasoned.

"The FDA is beset by companies hoping to make health claims," Thun
said. "The FDA's reasoning for the decision was clearly laid out."

Thun said he also wonders whether the health claims made for lycopene
truly come from lycopene. "Foods are complex mixtures, and it is a leap
of faith to say that one substance in isolation is the reason for the
benefit. In addition, things that come in the context of a complex food
are different from things that come in isolation at a different dose," he
said.

The FDA must ensure that health claims, either direct or implied, are
adequately supported by evidence, Thun said. "The FDA clearly put a lot
of work into this review," he said.

SOURCES: Brooke Holve, spokeswoman, American Longevity, San Diego,
Calif.; Michael Thun, M.D., vice president, Epidemiology and Surveillance
Research, American Cancer Society, Atlanta

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